Kornimate/medical-research-clean huggingface dataset:
support for frail elderly persons - from prevention to palliation

Conditions: Frail Elderly Persons

Summary: the present study "elderly person in the risk zone" form part of the research programme "support for frail elderly persons - from prevention to palliation" (www. vardalinstitutet.net) which comprises research into three interventions. a fundamental principle in the research programme is that it comprises interventions addressing frail elderly person in different phases of the disablement process, from elderly persons who are beginning to develop frailty to very frail elderly persons receiving palliative care in the final period of their lives. the interventions also address the different requirements that arise with regard to professional contributions during the various phases of the ageing and disease process, ranging from health promotion to a need for an increasing degree of medical care, nursing, special care and rehabilitation, and finally, efforts that promote symptom relief, quality of life, security and satisfaction with care during the final period of life. the intervention "elderly persons in the risk zone" addresses elderly persons that are on the point of developing frailty ("pre-frail") and are beginning to feel that they are being hindered from taking part in everyday activities. the hypothesis is that if an intervention is made when the persons are not so frail, it is possible to prevent/delay deterioration. 1. can a health-promoting and preventive intervention for "prefrail" elderly persons: * prevent frailty, activity limitations and morbidity, * be a supportive factor in the social and physical environment, * affect life satisfaction * have an impact on the consumption of care * be cost-effective? 2. how do the frail elderly persons experience the intervention and its importance to health?


Eligibility criteria:
inclusion criteria: * 80 years of age or older living in the community. * the participants should live in their ordinary housing * independent on formal support * independent on informal support * cognitive intact defined as a mini mental test score \> 25

Keywords: frailty health promotion prevention self management intervention
evaluation of orthopedic knee measurement using lunar idxa

Conditions: Hemi Knee Arthroplasty; Patello-femoral Osteoarthritis

Summary: this study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip.


Eligibility criteria:
inclusion criteria: 1. adult (\>30 years) males and females. 2. have had a hemi knee replacement of one knee at least 8 weeks ago. 3. patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint. 4. able to provide informed consent. 5. in good general health. exclusion criteria: 1. neuromuscular or vascular disease in the affected leg. 2. found to be unsuitable for hemi knee arthroplasty (ka) before or at surgery. 3. preoperative extensions defect greater than 15 degrees. 4. preoperative maximal flexion of less than 100 degrees. 5. symptomatic patello-femoral osteoarthritis. 6. insufficiency of anterior cruciate ligament (acl) 7. fracture sequalae (intraarticular fracture and all tibial condyle fractures). 8. previous osteotomy. 9. previous extensive knee surgery. 10. metabolic bone disease including osteoporosis with a t score of \<-2.5. 11. rheumatoid arthritis. 12. postmenopausal women on systemic hormone replacement therapy (hrt). 13. long-term treatment with oral corticosteroids and/or bisphosphonates. 14. inability to consent (such as alzheimer's disease). 15. misuse of drugs or alcohol. 16. serious psychiatric disease. 17. disseminated malignant disease and treatment with radiotherapy or chemotherapy.

Keywords: patello femoral osteoarthritis arthroplasty
internet surveys and their impact on adherence for rosacea

Conditions: Rosacea

Summary: an investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. all subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.

an investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. all subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.subjects will be randomized 1:1 to be in the weekly internet survey group or the standard care non-survey group. at each visit, review of the internet survey use will be done to assess adherence to the medication. . disease severity measures ((clinician's erythema assessment (cea), and lesion counts will be obtained. qol will be measured.

Eligibility criteria:
inclusion criteria: * male or female subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent. * have an investigator global assessment of mild to moderate rosacea (iga rating between 2 and 5 in the investigator global assessment score which includes erythema in the assessment). * access to a computer and the internet. exclusion criteria: * initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome. * use of topical therapy for rosacea within 2 weeks of baseline. * use of systemic corticosteroids within 4 weeks of baseline. presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments. * subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein. * female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded. * subjects with severe cardiovascular disease or vascular insufficiency.
the impact of expressive emotional writing on facilitating grief resolution in adults with spinal cord injury

Conditions: Spinal Cord Injuries; Transverse Myelitis

Summary: the aim of this study is to evaluate the therapeutic benefits of a 10-week online coach-guided eewp on psychosocial health among adults with sci.

paralysis in people with spinal cord injury (sci) leads to grief from the loss of physical capacity, social or occupational role function, and life goals. expressive emotional writing (eew) provides an outlet for these individuals to explore and express feelings and emotions that arise from their losses related to limb paralysis. using a randomized controlled trial design, the proposed project will attempt to confirm the benefits of an online coach-guided eew program for improving psychosocial health among adults with sci. benefits of participating in the program will be evaluated using validated assessments to measure reduction of grief intensity and improvement in other psychosocial dimensions and social participation.

Eligibility criteria:
inclusion criteria: (1) diagnosis (with evidence) of sci (traumatic or non-traumatic) with limb weakness; (2) aged \> 18 years; (3) access to the internet and a computer or to a smartphone that can perform videoconferencing, (4) sufficient english language and cognitive proficiency to complete self-report study questionnaires and understand program content in english, and able to communicate verbally or through writing. - exclusion criteria: (1) severe cognitive impairments that prevent online learning and completion of the evaluation; (2) suicidal intent requiring emergency care; (3) consistent psychotherapy within the last 6 months; (4) current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study; or (5) congenital sci (e.g., spinal bifida) -
cp-751,871 in combination with docetaxel in advance non-hematologic malignancies

Conditions: Advanced Non-Hematologic Malignancies

Summary: this clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of cp 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option * eastern cooperative oncology group \[ecog\] performance status 0-1 exclusion criteria: * significant active cardiac disease * chemotherapy, biological or investigational agents within 4 weeks prior to dosing * inadequate bone marrow, renal, cardiac or liver function

Keywords: non-hematologic cancer advanced solid tumors prostrate cancer
cyp2d6 genotypes and breast cancer clinical outcomes in the indonesian population

Conditions: Breast Cancer

Summary: the utilization of tamoxifen is considerably high in indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. it is metabolized by the enzyme cyp2d6, resulting in its active metabolite, endoxifen, which has been proven to be effective in the prevention and treatment of breast cancer. studies showed the cyp2d6 gene has more than 100 variants; some of which are linked with reduced drug activity, while others do not have any pathological implications. the metabolizer profile of these variants is generally grouped into ultra-rapid, normal, intermediate, and poor metabolizers (um, nm, im, and pm, respectively). in our previous study (nct04312347), the investigators recruited 150 breast cancer patients who were taking adjusted dose of tamoxifen daily based on their cyp2d6 phenotype. although the investigators have measured the endoxifen level of the patients with adjusted treatment, the clinical outcomes of the study are not yet conclusive.


Eligibility criteria:
inclusion criteria: 1. female 2. diagnosed with er+ breast cancer 3. have been genotyped and classified as pm and im in the previous study 4. are recommended by doctor to take tamoxifen 40 mg according to their metabolizer profile 5. have finished the definitive therapy course (surgery, chemotherapy, or radiotherapy). exclusion criteria: 1. have other primary cancer aside from breast cancer. 2. those with residual tumor cells/have experienced second primary breast tumor. 3. patients who are recommended by doctor to switch to aromatase inhibitors (ai)
value of right-sided hemicolectomy for chldren with high-risk neuroendocrine tumors of the appendix

Conditions: Neoplasms; Appendix Cancer

Summary: the goal of this observational study is to investigate the beneficial value of complementary surgery for appendiceal neuro-endocrine tumours in children. .

aim current guidelines recommend complementary right-sided hemicolectomy for high-risk (pt2(with risk factors)/pt3) neuro-endocrine tumors (net) of the appendix (based on adult studies). in contrast to adults, high-risk net of the appendix in children seems to be a relatively benign disease with high disease-free survival (100% versus 70-80% in adults), but high quality data are lacking. therefore these recommendations are now being questioned. we aim to investigate the value of complementary right-sided hemicolectomy for children with high-risk net of the appendix. ultimately leading to the development of a consensus guideline and solid information for patients/parents. plan of investigation in order to generate big data, an international historical cohort study is planned to compare complementary right-sided hemicolectomy with appendectomy alone for children with high-risk net of the appendix. results will be confidential used by an international expert group to formulate treatment recommendations. subsequently, these recommendations will be tested in an international delphi study in order to develop a consensus guideline on the treatment of pediatric high-risk net of the appendix. expected results the cohort study will generate high quality information on overall/disease-free survival, recurrence, complications, costs, and hr-qol. recommendations made will be tested in a delphi study; not only on the beneficial value of complementary right-sided hemicolectomy, but also on follow-up protocols and preoperative work-up. ultimately, an international consensus guideline that redefines low-risk and high-risk net of the appendix will be developed, leading to global de-escalation and uniformity of treatment. relevance for childhood cancer results are relevant for pediatric oncologists/surgeons/gastro-enterologists across the world, as redefining low-risk and high-risk patient groups, will lead to de-escalation of treatment. furthermore, qol of child and parents can be improved by reducing exposure to complications after complementary right-sided hemicolectomy, and by reducing the fear of recurrence by obtaining high-quality data to accurately inform patients and parents.

Eligibility criteria:
inclusion criteria: * all patients that were treated for an appendiceal net before the age of 18 years old * time period: 1990-2020 exclusion criteria: * other appendiceal malignancies/tumours, for example: * goblet cell carcinoma * adenocarcinoma * neuroendocrine carcinoma
effect of selective cox-2 inhibitor (etoricoxib) along with scaling and root planing (srp) on clinical parameters and salivary level of superoxide dismutase in chronic generalized periodontitis a double-blind, placebo-controlled, double-masked randomized controlled trial (rct).

Conditions: Cyclooxygenase Two Inhibitors; Etoricoxib; Periodontitis; Superoxide Dismutase; Saliva

Summary: the hypothesis is that etoricoxib act as an adjuvant to srp in alleviating periodontal inflammation by: 1. improving clinical periodontal parameters and, 2. improving the salivary sod levels.


Eligibility criteria:
inclusion criteria:forty patients with chronic generalized periodontitis - exclusion criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.

Keywords: cyclooxygenase two inhibitors etoricoxib periodontitis superoxide dismutase saliva
prospective, multi-centre, non-interventional study to investigate the effectiveness of rekovelle® for ovarian stimulation for asian women in real world settings

Conditions: Infertility

Summary: primary objective is to investigate the effectiveness of rekovelle® in women undergoing their first rekovelle® ovarian stimulation treatment in real world practice in asian countries.


Eligibility criteria:
inclusion criteria: * females aged 20 years or older at enrollment * serum amh level \>0.5 ng / ml (with the latest result tested within 12 months) * who are first time prescribed rekovelle for their ovarian stimulation and ivf or icsi treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable) * willing and able to provide written informed consent exclusion criteria: * have undergone more than 2 cos-ivf / icsi cycles before the enrollment * participating in an interventional clinical trial in which any medication treatment is mandated * women with a contraindication for prescription of rekovelle treatment * oocyte donors * undergoing ovarian stimulation for fertility preservation
oxytocin trial in prader-willi syndrome

Conditions: Prader Willi Syndrome

Summary: individuals with prader-willi syndrome (pws) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this study is to determine if oxytocin (ot) administration will improve some of the aspects of prader-willi syndrome that are particularly troublesome for children and their families (the insatiable appetite and social behaviors). the research questions are: 1. does intranasal oxytocin cause any side effects in children with pws? 2. does intranasal oxytocin administration alter appetite or behaviors in pws?

this study is to investigate if intranasal oxytocin will improve hyperphagia, social skills, and behaviors in subjects with prader-willi syndrome. this will be a randomized placebo controlled pilot study. the primary outcome measure is to determine if intranasal administration of oxytocin will cause any adverse events in subjects with prader-willi syndrome. secondarily, the investigators will also perform evaluations to determine if intranasal oxytocin has any effect on social skills, behaviors, or appetite in children with prader-willi syndrome.

Eligibility criteria:
inclusion criteria: * children with genetically confirmed pws * ages at ≥ 5 years and ≤ 11 years (must start treatment prior to 11th birthday) * child must be in nutritional phase 2b or 3, as determined by the pi at each site. * must currently be on growth hormone treatment, and have been receiving growth hormone treatment for at least one year prior to screening date. * treatment cannot have been interrupted for more than 1 week within 3 months prior to screening date. * priority will be given to children currently enrolled in the rdcrn natural history study exclusion criteria: * inability to tolerate intranasal administration of medication * hepatic insufficiency (ast/alt greater than 3 times the normal levels for age) * renal insufficiency (bun/creatinine greater than 3 times the normal levels for age) * history of an abnormal ecg (as determined by a cardiologist). if there is any question about cardiac function, ecg reports will be reviewed with a cardiologist prior to enrollment in the study. * child not receiving growth hormone treatment * child with hypertension or hypotension for age and sex (blood pressure \>97% for age and sex or blood pressure \<3% for age and sex) * diabetes mellitus * pregnant or lactating. * schizophrenia or psychosis * taking any psychotropic medications

Keywords: prader willi syndrome oxytocin
assessment of efficacy & safety for a new wound dressing urgo 310 3166 in the local treatment of vlu or mixed leg ulcers

Conditions: Leg Ulcers

Summary: assessment of efficacy and safety for a new wound dressing urgo 310 3166 in the local treatment of venous or mixed leg ulcers: a european, randomised clinical trial.


Eligibility criteria:
inclusion criteria: * patient over 18 years old who has provided his/her written informed consent, * patient who can be monitored by the same investigation team throughout the whole duration of the study, * patient who agrees to wear an effective venous compression system every day, associated with the trial dressing, * leg ulcer with an ankle brachial pressure index (abpi) not less than 0.7 and not more than 1.3, * ulcer area \> or equal to 5cm2, * ulcer duration \> or equal to 6 months, * ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue, * moderately or heavily exudative ulcers. exclusion criteria: * clinical infection on the wound bed.
request for single patient ind for compassionate/emergency use of tocilizumab

Conditions: Juvenile Idiopathic Arthritis

Summary: application for compassionate use of tocilizumab in a boy with severe polyarticular juvenile idiopathic arthritis (jia) unresponsive to all licensed medications.

this trial is for a single subject with juvenile idiopathic arthritis unresponsive to all licensed treatments for jia, and some licensed only for rheumatoid arthritis. he is currently wheelchair bound and completely dependent for activities of daily living and self-care. he is in constant pain, has abundant warmth and swelling of nearly all joints including tmjs, neck, shoulders, elbows, wrists, mcp and finger joints (even some dip joints), hips, knees, ankles, subtalar and intertarsal joints, mtp and ip joints of the toes. drug at a dose of 8 mg/kg would be administered iv every 2 weeks, with close safety and monitoring studies. treatment would be monitored every 2 weeks. efficacy will be measured using the acr pedi 30, 50 and 90 definitions as previously published, based on: 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate.

Eligibility criteria:
inclusion criteria: * subject x, polyarticular jia, not responding to any other drug exclusion criteria: * not identified subject

Keywords: juvenile idiopathic arthritis
validation of procalcitonin as a biomarker diagnosing cdi

Conditions: Cardiac Implantable Electronic Device Infections

Summary: cardiac device infections (cdi), especially pocket infections, are difficult to be diagnosed. device pocket infections are not associated with elevated white blood cell count. crp is only assoziated with a low sensitivity. the diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. the prospective dirt study identified procalcitonin (pct) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection. the study aims to validate the proposed pct cut-off value of 0.05 ng/ml for the diagnosis of pocket infection


Eligibility criteria:
inclusion criteria: • device associated infections exclusion criteria: * malignancy * cytostatic or immunomodulating therapy
efficacy and safety of salonsip compared to sabiá plaster

Conditions: Contusions; Sprains; Myalgia; Pain; Tendonitis

Summary: the purpose of this study is to evaluate the efficacy in reducing signs and symptoms in patients with contusions, sprains, muscular injuries and injuries with less than 24 hours early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with salonsip compared to sabiá plaster. it is clinical, open, multicenter, randomized, prospective and comparative, with patients entering at random. patients will be included in sufficient quantity to achieve the minimum number of 70 evaluable patients.


Eligibility criteria:
inclusion criteria: * patients of both sexes, of any race, aged 12 years; * ability to read, understand and sign the consent form, in the case of children under age monitoring and consent of the person responsible; * clinical diagnosis of bruises, sprains, trauma, muscle damage occurring in times less than 24 hours or myalgia, pain miofasciais or tendonitis. * patients able to understand and maintain the clinical protocol exclusion criteria: * known hypersensitivity to components of the formulas of both the product and the comparative test. * known hypersensitivity to paracetamol. * location of the lesion with skin wound or irritated. * hepatic or renal diseases known. * pregnant or breastfeeding. * patients who require surgery or immobilization rigid; * patients with fractures or rupture of the ligaments. * patients in use of anticoagulants. * patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart disease, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, infections, hormonal disorders and pulmonary disorders. * history of alcoholism or use of illicit drugs; * use of non-steroidal anti-inflammatory drugs, corticosteroids or venoterápicos, topics or any other form of administration. * conditions which in the opinion of the investigator makes the patient unsuitable to participate in the study.

Keywords: plaster injuries regions miofasciais articulated reducing signs, symptoms